Naturelle 25176598

GUDID 10729661269454

Individually wrapped tampons

IMPACT PRODUCTS, LLC

Menstrual tampon, unscented

• Primary Device ID: 10729661269454
• NIH Device Record Key: 3a98c543-6f59-48bc-b028-679df2294b11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Naturelle
• Version Model Number: 25176598
• Catalog Number: 25176598
• Company DUNS: 005052360
• Company Name: IMPACT PRODUCTS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com
• Phone: 419-841-2891
• Email: compliance@impact-products.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10729661269454 [Primary]
HIBCC	B3402517650 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031067

FDA Product Code

• HEB: Tampon, Menstrual, Unscented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-09
• Device Publish Date: 2024-02-01

On-Brand Devices [Naturelle]

• B34025160273: Individually packaged tampon
• B34025030073: Pantyliners
• 10729661269454: Individually wrapped tampons
• 10729661269447: Individually wrapped tampon
• 10729661269348: Individually wrapped tampon